Osteo Arthritis KneeNCT06339151
Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA
A study testing Dexamethasone before surgery, Dexamethasone before and 12 hours after surgery and Dexamethasone before and 24 hours after surgery in people with Osteo Arthritis Knee and Pain, Postoperative, run by Thammasat University Hospital at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement. The main question[s] it aims to answer [is/are]: Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee, Pain, Postoperative
- What is being tested?
- Dexamethasone before surgery, Dexamethasone before and 12 hours after surgery and Dexamethasone before and 24 hours after surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 23 Mar 2022to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary osteoarthritis of knee joint
- Undergo unilateral primary total knee replacement
- Age between 50-85 years old
Who cannot join
- Allergy to dexamethasone
- History of long term corticosteroid used
- New York heart association (NYHA) class > II
- Type 2 Diabetes mellitus that had HbA1c > 7 % or FBS > 200 mg/dl
- Chronic kidney disease > stage III or eGFR < 60
- Cirrhosis Child class B or C
Show all 9Show fewer
- Cannot use pain controlled as protocol
- History of previous knee surgery
- History of previous septic arthritis at knee joint
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: Efficacy of Intravenous Dexamethasone Injection Given 12 and 24 Hours for Pain After Total Knee Arthroplasty: A Prospective Randomized Clinical Trial
The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement.
The main question[s] it aims to answer [is/are]:
Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement?
Researchers will compare double dose of dexamethasone group to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Read the detailed description
- Randomized patients into 3 groups
- Group 1: Patients received only Dexamethasone 0.15 mg/kg IV before surgery.
- Group 2: Patients received Dexamethasone 0.15 mg/kg IV before surgery and Dexamethasone 0.15 mg/kg at 12 hours after surgery.
- Group 3: Patients received Dexamethasone 0.15 mg/kg before surgery along and Dexamethasone 0.15 mg/kg at 24 hours after surgery.
- Preemptive analgesia Alprazolam 0.5 mg. 1 tablet, Pregabalin 75 mg. 1 tablet before bedtime Celecoxib 400 mg. 1 tablet, Omeprazole 20 mg 1 mg tablet, Paracetamol 500 mg 2 tablets and 1 Ondansetron 4 mg 1 tablet at 1 hour before surgery.
- The researcher will give an injection. Dexamethasone 0.15 mg/kg injection form together with Cefazolin 1 gm injection form by the anesthesiologist 30 minutes before surgery.
- Spinal Anesthesia by an anesthesiologist before surgery The anesthetic component consists of 0.5% Bupivacaine 15 mg, which does not contain morphine, along with local anesthesia in the thigh area (Adductor canal block) with a mixture of 0.5% Bupivacaine 15 mg.
- All patients will undergo knee replacement surgery in the same manner
- Periarticular cocktail injection The drug contains Tranexamic acid 10 mg/kg, Morphine 5 mg, Adrenaline 0.5 mg, 5% Bupivacaine 200 mg (Marcaine 1 amp), Ketorolac 30 mg (1 amp) mixed with saline (Normal saline) until 75 ml of area is obtained. The injection site is placed around the knee joint and knee capsule.
- After surgery, the patient will stay in the recovery room for 2 hours to take care of their symptoms.
- Pain relievers after surgery include
- Parecoxib (Dynastat) 40 mg injection every 12 hours for the first 2 days after knee replacement surgery, then change the medicine to Celecoxib 400 mg. 1 tablet after breakfast
- Paracetamol 500 mg. 2 tablets every 6 hours for the first 2 days after knee replacement surgery. After that, give Paracetamol 500 mg. 2 tablets pro for pain every 6 hours
- Pregabalin 75 mg. 1 tablet po hs
- Morphine 3 mg injection every 4 hours for patients with a pain score greater than 4 points (VAS-P score ≥4)
- Ondansetron 4 mg IV prn for nausea and vomitting every 6 hours
- Alprazolam 0.5 mg 1 tab po hs
- Cefazolin 1 gm IV every 6 hours for the first 24 hours after surgery
- Group 2 patients will receive Dexamethasone 0.15 mg/kg as an injection after surgery at 12 hours, and patients in Group 3 will receive Dexamethasone 0.15 mg/kg as injection at 24 hours after surgery
- Conditions
- Osteo Arthritis Knee, Pain, Postoperative
- Being tested
- Dexamethasone before surgery, Dexamethasone before and 12 hours after surgery, Dexamethasone before and 24 hours after surgery
- Keywords
- total knee arthroplasty, dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone before surgeryDrug
Dexamethasone 0.15 mg/kg IV before surgery
Dexamethasone before and 12 hours after surgeryDrug
Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 12 hours post operation
Dexamethasone before and 24 hours after surgeryDrug
Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 24 hours post operation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery.
Postoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Normal saline solution injection Receives: Drug: Dexamethasone before surgery |
| Group 2 | Active comparator | Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery.
Postoperative 12 hr - Dexamethasone 0.15 mg/kg IV at 12 hours post operation Postoperative 24 hr - Normal saline solution injection Receives: Drug: Dexamethasone before and 12 hours after surgery |
| Group 3 | Active comparator | Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery.
Postoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Dexamethasone 0.15 mg/kg IV at 24 hours post operation Receives: Drug: Dexamethasone before and 24 hours after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest and motion
Using visual analog scale 0-10 (0 means best, 10 means worst)
Measured: At 6 hour, 12 hour, 18 hour, 24 hour, 30 hour, 36 hour, 42 hour, 48 hour, 54 hour, 60 hour, 66 hour and 72 hour after surgery
Secondary outcomes (7)
Nausea and vomiting
Using visual analog scale 0-10 (0 means best, 10 means worst)
Measured: At 24 hour, 48 hour and 72 hour after surgery
Morphine consumption
Total milligrams use of morphine postoperative (record in mg)
Measured: At 24 hour, 48 hour and 72 hour after surgery
Blood sugar level
record in mg/dL
Measured: At 24 hour and 48 hour after surgery
CRP level
record in mg/dL
Measured: At 24 hour and 48 hour after surgery
Range of motion
Using long arm goniometer (record in degrees)
Measured: At 24 hour and 48 hour after surgery
Length of hospital stay
Number of days the patient stays for surgery
Measured: up to 1 week
Complication
Surgical site infection, deep infection or wound complication
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start23 Mar 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yot Tanariyakul, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339151
- Sponsor's protocol ID
- TUH multiple dexamethasone TKA
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu H, Zhang S, Xie J, Lei Y, Cao G, Pei F. Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. J Arthroplasty. 2018 Nov;33(11):3448-3454. doi: 10.1016/j.arth.2018.06.031. Epub 2018 Jul 4.
PubMed 30033064
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Dexamethasone Injection Given 12 and 24 Hours for Pain After Total Knee Arthroplasty: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06339151
- Acronym / sponsor ID
- TUH multiple dexamethasone TKA
- Conditions
- Osteo Arthritis Knee, Pain, Postoperative
- Keywords
- total knee arthroplasty, dexamethasone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement.
The main question[s] it aims to answer [is/are]:
Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement?
Researchers will compare double dose of dexamethasone group to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Detailed description
- Randomized patients into 3 groups
- Group 1: Patients received only Dexamethasone 0.15 mg/kg IV before surgery.
- Group 2: Patients received Dexamethasone 0.15 mg/kg IV before surgery and Dexamethasone 0.15 mg/kg at 12 hours after surgery.
- Group 3: Patients received Dexamethasone 0.15 mg/kg before surgery along and Dexamethasone 0.15 mg/kg at 24 hours after surgery.
- Preemptive analgesia Alprazolam 0.5 mg. 1 tablet, Pregabalin 75 mg. 1 tablet before bedtime Celecoxib 400 mg. 1 tablet, Omeprazole 20 mg 1 mg tablet, Paracetamol 500 mg 2 tablets and 1 Ondansetron 4 mg 1 tablet at 1 hour before surgery.
- The researcher will give an injection. Dexamethasone 0.15 mg/kg injection form together with Cefazolin 1 gm injection form by the anesthesiologist 30 minutes before surgery.
- Spinal Anesthesia by an anesthesiologist before surgery The anesthetic component consists of 0.5% Bupivacaine 15 mg, which does not contain morphine, along with local anesthesia in the thigh area (Adductor canal block) with a mixture of 0.5% Bupivacaine 15 mg.
- All patients will undergo knee replacement surgery in the same manner
- Periarticular cocktail injection The drug contains Tranexamic acid 10 mg/kg, Morphine 5 mg, Adrenaline 0.5 mg, 5% Bupivacaine 200 mg (Marcaine 1 amp), Ketorolac 30 mg (1 amp) mixed with saline (Normal saline) until 75 ml of area is obtained. The injection site is placed around the knee joint and knee capsule.
- After surgery, the patient will stay in the recovery room for 2 hours to take care of their symptoms.
- Pain relievers after surgery include
- Parecoxib (Dynastat) 40 mg injection every 12 hours for the first 2 days after knee replacement surgery, then change the medicine to Celecoxib 400 mg. 1 tablet after breakfast
- Paracetamol 500 mg. 2 tablets every 6 hours for the first 2 days after knee replacement surgery. After that, give Paracetamol 500 mg. 2 tablets pro for pain every 6 hours
- Pregabalin 75 mg. 1 tablet po hs
- Morphine 3 mg injection every 4 hours for patients with a pain score greater than 4 points (VAS-P score ≥4)
- Ondansetron 4 mg IV prn for nausea and vomitting every 6 hours
- Alprazolam 0.5 mg 1 tab po hs
- Cefazolin 1 gm IV every 6 hours for the first 24 hours after surgery
- Group 2 patients will receive Dexamethasone 0.15 mg/kg as an injection after surgery at 12 hours, and patients in Group 3 will receive Dexamethasone 0.15 mg/kg as injection at 24 hours after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Dexamethasone before surgeryPreoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery. Postoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Normal saline solution injection |
| Group 2 | Active comparator | Drug: Dexamethasone before and 12 hours after surgeryPreoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery. Postoperative 12 hr - Dexamethasone 0.15 mg/kg IV at 12 hours post operation Postoperative 24 hr - Normal saline solution injection |
| Group 3 | Active comparator | Drug: Dexamethasone before and 24 hours after surgeryPreoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery. Postoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Dexamethasone 0.15 mg/kg IV at 24 hours post operation |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary osteoarthritis of knee joint
- Undergo unilateral primary total knee replacement
- Age between 50-85 years old
Key exclusion criteria (9 listed)
- Allergy to dexamethasone
- History of long term corticosteroid used
- New York heart association (NYHA) class > II
- Type 2 Diabetes mellitus that had HbA1c > 7 % or FBS > 200 mg/dl
- Chronic kidney disease > stage III or eGFR < 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone before surgeryDexamethasone 0.15 mg/kg IV before surgery | Drug | Group 1 |
| Dexamethasone before and 12 hours after surgeryDexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 12 hours post operation | Drug | Group 2 |
| Dexamethasone before and 24 hours after surgeryDexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 24 hours post operation | Drug | Group 3 |
Primary outcome
Pain at rest and motion
Time frame: At 6 hour, 12 hour, 18 hour, 24 hour, 30 hour, 36 hour, 42 hour, 48 hour, 54 hour, 60 hour, 66 hour and 72 hour after surgery
Using visual analog scale 0-10 (0 means best, 10 means worst)
7 secondary outcomes
Nausea and vomiting
Time frame: At 24 hour, 48 hour and 72 hour after surgery
Morphine consumption
Time frame: At 24 hour, 48 hour and 72 hour after surgery
Blood sugar level
Time frame: At 24 hour and 48 hour after surgery
CRP level
Time frame: At 24 hour and 48 hour after surgery
Range of motion
Time frame: At 24 hour and 48 hour after surgery
Length of hospital stay
Time frame: up to 1 week
Complication
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 30033064Xu H, Zhang S, Xie J, Lei Y, Cao G, Pei F. Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. J Arthroplasty. 2018 Nov;33(11):3448-3454. doi: 10.1016/j.arth.2018.06.031. Epub 2018 Jul 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone before surgery, Dexamethasone before and 12 hours after surgery and Dexamethasone before and 24 hours after surgery in people with Osteo Arthritis Knee and Pain, Postoperative, run by Thammasat University Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at rest and motion (time frame: At 6 hour, 12 hour, 18 hour, 24 hour, 30 hour, 36 hour, 42 hour, 48 hour, 54 hour, 60 hour, 66 hour and 72 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06339151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.